Abstract
Background: Live attenuated influenza vaccine (LAIV) is recommended for annual influenza vaccination in children from age 2 years. However, some guidelines recommend against its use in children with asthma or recurrent wheeze due to concerns over its potential to induce wheezing. Objective: We sought to assess the safety of LAIV in children with moderate to severe asthma, and in preschool children with recurrent wheeze. Methods: Prospective, multicenter, open-label, phase IV intervention study in 14 specialist UK clinics. LAIV was administered under medical supervision, with follow-up of asthma symptoms 72 hours and 4 weeks late, using validated questionnaires. Results: A total of 478 young people (median, 9.3; range, 2-18 years) with physician-diagnosed asthma or recurrent wheeze were recruited, including 208 (44%) prescribed high-dose inhaled corticosteroids and 122 (31%) with severe asthma. There was no significant change in asthma symptoms in the 4 weeks after administration (median change, 0; P = .26, McNemar test), with no impact of level of baseline asthma control/symptoms in predicting either a worsening of asthma or exacerbation after LAIV using a regression model. A total of 47 subjects (14.7%; 95% CI, 11%-19.1%) reported a severe asthma exacerbation in the 4 weeks after immunization, requiring a short course of systemic corticosteroids; in 4 cases, this occurred within 72 hours of vaccination. No association with asthma severity, baseline lung function, or asthma control was identified. Conclusions: LAIV appears to be well tolerated in the vast majority of children with asthma or recurrent wheeze, including those whose asthma is categorized as severe or poorly controlled.
| Original language | English |
|---|---|
| Pages (from-to) | 1157-1164.e6 |
| Journal | Journal of Allergy and Clinical Immunology |
| Volume | 145 |
| Issue number | 4 |
| DOIs | |
| Publication status | Published - Apr 2020 |
Bibliographical note
Funding Information:This study is independent research funded by the National Institute for Health Research (NIHR) Policy Research Programme (National Vaccine Evaluation Consortium Phase II, 039/0031). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. P.J.T. was supported by a Clinician Scientist award funded by the UK Medical Research Council (reference MR/K010468/1), and has received research support from the Department of Health through the NIHR comprehensive Biomedical Research Centre award to Imperial College London Healthcare NHS Trust. The study received additional local support through the NIHR Clinical Research Networks. The sponsor of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The study design and data collection were performed independently of the funder; data analysis was performed in conjunction with Public Health England, who also contributed to the writing of this report. Disclosure of potential conflict of interest: P. J. Turner and E. Miller received support from the National Institute for Health Research (NIHR) Policy Research Programme for the submitted work. P. J. Turner and S. Saglani have received research grants from the UK Medical Research Council and the NIHR. L. Fleming reports other funding from GlaxoSmithKline, Sanofi, Novartis, Boehrringer Ingelheim, and Astra Zeneca, outside the submitted work. J. Southern is now employed by Pfizer, but only following data lock after completion of the study. N. J. Andrews reports no conflicts of interest, no other relationships, or activities that could appear to have influenced the submitted work.
Publisher Copyright:
© 2019 The Authors
Keywords
- Asthma
- children
- immunization
- influenza
- live attenuated influenza vaccine
